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Quadracel Vaccine Approved for Peds DTaP Series

Sanofi Pasteur announced that the Food and Drug Administration (FDA) has approved Quadracel (diphtheria and tetanus toxoids and acellular pertussis absorbed and inactivated poliovirus [DTaP-IPV]) vaccine for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis in children ages 4–6 years.

Quadracel is indicated for use as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series, and as a fourth or fifth dose in the inactivated poliovirus vaccination (IPV) series, in children who have received four doses of Pentacel (diphtheria and tetanus toxoids + acellular pertussis adsorbed + inactivated poliovirus vaccine (susp); Hib conjugate (tetanus toxoid conjugate, PRP) and/or Daptacel (diphtheria and tetanus toxoids, acellular pertussis vaccine; Sanofi Pasteur).

The approval of Quadracel vaccine was based on data from a Phase 3 multi-center, randomized, controlled study that compared the safety and immunogenicity of Quadracel vaccine with Daptacel and Ipol (trivalent poliovirus vaccine; inactivated; Sanofi Pasteur) vaccines in children ages 4–6 years who were previously vaccinated with Daptacel and/or Pentacel (DTaP-IPV/Hib) vaccines. Study results showed Quadracel vaccine had similar safety and immunogenicity profiles compared to those of separately administered Daptacel and Ipol vaccines.